Ultrasound Acupuncture for Oxaliplatin-induced Peripheral Neuropathy in Colorectal Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain level assessment
研究概览
简要总结
The current study was conducted to examine the effect of ultrasound acupuncture for oxaliplatin-induced peripheral neuropathy in colorectal cancer patients.
详细描述
Oxaliplatin is platinum-based chemotherapy most usually used for the treatment of metastatic colorectal cancer, this drug can produce a cumulative and dose-limiting distal sensory neuropathy affecting the majority of oxaliplatin-treated patients. Despite intense investigation at the preclinical and clinical levels, no treatment can be suggested for the prevention of OIPN. Since acupuncture has proven effective in alleviating the severity of peripheral nerve neuropathy, as has ultrasound.
This systematic review was conducted to test the ability of ultrasound acupuncture in decreasing neuropathy-related symptoms induced by oxaliplatin-based chemotherapies in colorectal cancer patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject selection was according to the following criteria:
- •Adults their ages ranged from 20 to 70 years old.
- •Receiving or have received chemotherapy treatment for colon or rectal cancer.
- •Chemotherapy regimen included the agent oxaliplatin.
- •Patients diagnosed with neuropathy by the oncologist.
- •Both sexes.
- •No neuropathy prior to oxaliplatin treatment.
- •No documented or observable psychiatric or neurological disorders that would interfere with study participation (eg, dementia or psychosis)
- •Stage II, III and IV colon or rectal cancer.
- •Hands and Feets were the most affected by CIPN.
- •The first dose of oxaliplatin was from 4 months or more.
排除标准
- •The potential participants were excluded in the following conditions:
- •Another malignancy
- •Patients with severe or unstable cardiorespiratory or musculoskeletal diseases that may influence the accuracy of quantitative sensory testing results.
- •Participants who cannot remain on the same medications throughout the study period with minor dose adjustments allowed.
- •Contraindications to therapeutic ultrasound including active cancer in region of hands or feet, presence of deep vein thrombosis, complete numbness in hands or feet (representing severe CIPN), metal or plastic implantation
- •Peripheral vascular disease in hands or feet.
研究组 & 干预措施
Active
Therapeutic ultrasound (1 MHz) Pulsed mode at bilateral acupuncture points of PC6, PC7, BL60 andKI1
干预措施: Therapeutic ultrasound (Device)
Active
Therapeutic ultrasound (1 MHz) Pulsed mode at bilateral acupuncture points of PC6, PC7, BL60 andKI1
干预措施: Traditional physical therapy program (Other)
Experime
Placebo Therapeutic ultrasound at bilateral acupuncture points of PC6, PC7, BL60, and KI1
干预措施: Placebo therapeutic ultrasound (Device)
Experime
Placebo Therapeutic ultrasound at bilateral acupuncture points of PC6, PC7, BL60, and KI1
干预措施: Traditional physical therapy program (Other)
结局指标
主要结局
Pain level assessment
时间窗: 2.5 months
In comfortable siting position we asked them to give each item from the 10-items score from 0 to 10 according to the intensity of the symptom, 0 means that the symptom is absent and 10 means maximum intensity. Sum of scores is 100, a higher score is associated with increased pain
Assessment of pain pressure threshold
时间窗: 2.5 months
Pain pressure threshold at hand and foot was measured by using a digital pressure algometer with a probe of 1 cm2 .PPT at feets was measured on the plantar foot surface over the second metatarsal. PPT at hands was measured on thenar eminence of the hand
次要结局
- National Cancer Institute Common Toxicity Criteria(2.5 months)
研究者
Hend Ali Mahmoud Ibrahim Badr Al-din
Principal investigator
Cairo University